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MSD Clinical Research Manager m/w/d Germany, Rhineland-Palatinate 250469828
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Job Description
The primary function of the Clinical Research Manager position is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires the candidate to be responsible for the conduct of Good Clinical Practice (GCP) studies, and occasionally Good Laboratory Practice (GLP) studies.
The Clinical Research Manager acts primarily as clinical study team leader and has overall responsibility for a study. Specifically, the CRM has the following tasks and responsibilities:
Responsibilities:
Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements. This includes the setting of objectives, budget, resources, timelines and the study protocol/related documentation
Provide overall leadership and support to the study team
Identify and select Investigators, laboratories and/or CROs.
Ensure compliance of the study with GCP, applicable legislation and our Company's policies and procedures.
Plan and coordinate the monitoring and data management activities of each study.
Prepare the Final Study Report.
As GMP Study Product Manager ensure GMP compliant labelling of Clinical Trial Material
Prepare critical summaries and expert reports to management and/or for submission to regulatory agencies
Requirements:
A Doctor of Veterinary Medicine, OR equivalent veterinary degree (An advanced degree e.g. PhD desired)
A minimum of four years of experience in clinical research or similar research role.
Strong scientific writing ability.
Good communication skills, excellent English language proficiency (C1) every other European language is a plus
Our Benefits
Varied areas of responsibility
Contributing your own ideas to the process design
Collaboration in the development of veterinary medicinal products
Insights into the workings of a large company
Numerous training and further education opportunities
Small site in a beautiful location with a family atmosphere
Payment according to collective agreement, long-term account, company pension scheme
Hybrid working model with with up to 50% home office and presence at the Schwabenheim site
Own canteen
Health support (massages, health day, resources for living)
Company bike, corporate benefits, (electric) car parking spaces
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
Job Posting End Date:08/03/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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